Xenoview Gas
NDC Package 80534-0750-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xenoview (xenon xe 129 hyperpolarized) gases is xENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. This formulation utilizes a gas delivery system. Marketed by Polarean, Inc., this product is identified by NDC 80534-0750 and is authorized under FDA application NDA214375.

Identification & Billing

NDC Package Code
80534-0750-1
Package Description
50 BAG in 1 CARTON / 750 mL in 1 BAG
Product Code
80534-0750
11-Digit Billing Format
80534075001

Clinical Specifications

Proprietary Name
Xenoview
Non-Proprietary Name
Xenon Xe 129 Hyperpolarized
Substance Name
Xenon Xe-129, Hyperpolarized
Dosage Form
Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
XENON XE-129, HYPERPOLARIZED 75 mL/750mL
Pharmacologic Class
Usage Information
XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging.

Regulatory & Marketing

Labeler Name
Polarean, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214375
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80534-0750-1 identifies a specific commercial package of 50 bag in 1 carton / 750 ml in 1 bag of Xenoview, a human prescription drug labeled by Polarean, Inc.. This gas is formulated for respiratory (inhalation) use and contains xenon xe-129, hyperpolarized as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Polarean, Inc. on December 23, 2022. The current certification is valid through December 31, 2026.

How is this Polarean, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80534075001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
80534-0750-1
11-Digit CMS (5-4-2)
80534-0750-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.